Valve for bladder control device

ABSTRACT

A valve for a bladder control device including an elongate housing having a valve seat disposed therein. A stopper is also disposed within the housing and is moveable between a first position in which the stopper engages the valve seat and a second position wherein the stopper is moved distally of the valve seat. A tension spring can be connected to the stopper to biases the stopper toward the valve seat. A lumen is defined through the housing having a first portion disposed distally of the valve seat having a diameter approximately equal to a diameter of the stopper. A second portion of the lumen disposed distally of the first portion has a greater diameter than the first portion of the lumen. Yet a third portion of the lumen disposed distally of the second portion has a diameter less than that of the first portion.

BACKGROUND OF THE INVENTION

[0001] The present invention relates generally to the field of bladdercontrol devices. More particularly, the invention relates to the fieldof bladder control devices in which a valve is provided to control flowfrom the bladder of a patient.

[0002] Bladder control devices related to the field of this inventioninclude devices such as those disclosed by Kulisz et al., in U.S. Pat.No. 5,512,032 and U.S. Pat. No. 5,701,916. The former patent discloses abladder control device including a valve which remains open under theinfluence of flow through the device in accordance with Bernoulli'sPrinciple. The latter patent discloses proximally and distally disposedretainers for retaining the bladder control device within a patient'surethra. These pioneering devices can be activated in an intuitive wayby a patient, simply by the patient increasing bladder pressure. Thevalve remains open at a lower pressure so long as a certain minimal flowrate through the valve continues. When the flow subsides, the valvecloses.

[0003] Intraurethral bladder control devices are disposed within theurethra during use. Consequently, patients and their physicians desirethat the diameter of the device be limited without compromising theperformance of the device. It can be appreciated that larger diameterbladder control devices could cause some discomfort during insertion anduse. Scaling down a device, i.e., making a smaller device having thesame configuration, will reduce the flow through the deviceexponentially. Reducing flow through the valve limits the forcecreatable by the Bernoulli's Principle to hold the valve open.Additionally, if the diameter of a compression spring, as used in theprior devices to bias the valve close, is scaled down, the spring issubject to buckling, which could leave the valve in a permanently openposition.

SUMMARY OF THE INVENTION

[0004] The present invention pertains to a valve for a bladder controldevice which incorporates features allowing the device to be effectivewhen produced in small diameters, such as 18 F, for example. The valvefor a bladder control device in accordance with the present inventionincludes an elongate housing which has a proximal end and a distal end.A lumen extends through the housing. A valve seat is disposed within thehousing and a stopper is disposed within the housing. The stopper ismoveable between a first position engaging the valve seat and a secondposition disposed distally of the valve seat. In the first position, thevalve is closed, in the second position the valve is at least partiallyopen.

[0005] The valve in accordance with the present invention, preferablyincludes a tension spring connected to a stopper to bias the stoppertoward the valve seat. The spring is under greater tension loading whenthe stopper is in the second position that when the stopper is in thefirst position. The spring can include an elongate shaft portion havinga proximal end and a distal end. The proximal end of the shaft portionis preferably connected to the stopper and the distal end of the shaftportion is preferably connected to a helical portion of the spring.

[0006] The stopper can include a proximal portion having a firstdiameter generally sized to engage the valve seat. The stopperpreferably has a distal portion having a diameter greater than thediameter of the proximal portion.

[0007] The lumen through the housing can include a portion disposeddistally of the valve seat having a diameter approximately equal to thediameter of the distal portion of the stopper. The stopper is preferablyslidably disposed within this portion of the lumen for movement betweenthe first and second positions. A second portion of the lumen, disposeddistally of the first portion of the lumen, has a diameter greater thanthe diameter of the first portion of the lumen. The lumen alsopreferably includes a third portion disposed distally of the secondportion of the lumen which has a diameter less than the diameter of thesecond portion of the lumen. This region of the lumen, in conjunctionwith the larger diameter distal portion of the stopper, can induce thedesired force in accordance with Bernoulli's Principle to retain thestopper in the second position so long as a certain minimum flow ratethrough the lumen is maintained.

[0008] The housing in the valve of the present invention preferably hasan outer diameter of between about 16 F to 22 F, and more preferably,about 18 F. It can be appreciated, however, that valves having greateror lesser outside diameters may also be made in accordance with thepresent invention.

BRIEF DESCRIPTION OF THE DRAWINGS

[0009]FIG. 1 is a cross sectional view of a valve in accordance with thepresent invention wherein the stopper is shown in engagement with avalve seat;

[0010]FIG. 2 is a cross sectional view of the valve of FIG. 1, whereinthe stopper is moved distally away from the valve seat; and

[0011]FIG. 3 is a view of the valve of FIG. 2, wherein the stopper ismoved yet further distally to open the valve.

DETAILED DESCRIPTION OF THE INVENTION

[0012] Referring now to the drawings wherein like reference numeralsrefer to like elements throughout the several views, FIG. 1 is aschematic cross sectional view of a valve 10 for a bladder controldevice in accordance with the present invention. Housing 12 can beformed from a biocompatible polymer, metal or other material. Housing 12can be formed from a single piece or from an assembly of several pieces.

[0013] Valve 10 includes an elongate housing 12 having a lumen 14extending therethrough from a proximal end 16 to a distal end 18. Valve10 can be placed in the urethra of a patient. It can be retained withinthe urethra by proximal and distal retainers such as those disclosed inU.S. Pat. No. 5,701,916 to Kulisz et al. which is incorporated herein byreference. It should be understood, however, that the use of this valveis not limited to a configuration including the proximal and distalretainers of the referenced U.S. patent. It is contemplated that thevalve could be used for bladder control of both male and femaleincontinence.

[0014] A valve seat 20 is disposed within housing 12. Valve seat 20 canbe a narrow or constricted diameter region of the lumen 14. The diameterof seat 20 is D₁ (Radius, R₁=D₁/2). Distally of valve seat 20 is a firstlumen portion 22 having a diameter D (Radius, R₃=D₃/2). Lumen 14includes a second lumen portion 24, disposed distally of first lumenportion 22, which has a diameter D₄ (Radius, R₄=D₄/2). Diameter D₄ isgreater than diameter D₃. Lumen 14 also includes a third lumen portion26 disposed distally of second lumen portion 24. Third lumen portion 26has a diameter D₅ which is less than diameter D₄. Lumen 14 tapers alonga slope 28 between second lumen portion 24 and third lumen portion 26.

[0015] Disposed within housing 12 is a stopper 30. Stopper 30 preferablyhas a proximal portion 31 configured for engagement with valve seat 20.Proximal portion 31 has a diameter of D₁. Disposed distally of proximalportion 31 is a portion 32 having a diameter D₂ (Radius, R₂=R₂/2) lessthan D₃ of first lumen portion 22. Yet more proximally, stopper 30includes a plunger portion 34 having a diameter approximately equal to,but less than D₃ of first lumen portion 22. Stopper 30 includes asloping portion 35 sloping from plunger portion 34 to the distal end ofstopper 30. Stopper 30 can be from a polymer, metal or otherbiocompatible material.

[0016] Disposed within housing 10 is a spring 36 for biasing stopper 30toward valve seat 20. Spring 36 is preferably disposed distally of valveseat 28. Spring 36 is preferably a tension spring include an elongateshaft portion 40 having a proximal end connected to stopper 30 and adistal end connected to a helical spring portion 38. The opposite end ofspring portion 38, not connected to shaft 40, can be affixed to housing12 at, for example, a circumferential stop 42. Spring 40 can be madefrom stainless steel, NiTi alloy or other biocompatible material andsuitable for the intended use.

[0017] A preferred relationship between R₁, R₂, R₃, and R₄ can bedetermined solving three equations. Assuming that R₄, the maximum innerdiameter of lumen 14, is a given and that ΔR=R₂−R₁, then R₁, R₂ and R₃can be found using the following formulas: $\begin{matrix}{R_{1} = \frac{{{- \Delta}\quad R} + \sqrt{{3 \cdot R_{4}^{2}} - {{2 \cdot \Delta}\quad R^{2}}}}{3}} & (1) \\{R_{2} = {R_{1} + {\Delta \quad R}}} & (2) \\{R_{3} = \sqrt{R_{1}^{2} + R_{2}^{2}}} & (3)\end{matrix}$

[0018] The formulas given are preferred formulas, but can be viewed asexemplary. The length of first lumen portion 22 is preferably longenough that stopper 30 can move somewhat longitudinally therethroughwithout allowing flow through lumen 14. This could dampen spikes inbladder pressure without opening valve 10. This is an optional featurewhich is viewed as desirable.

[0019] Housing 12 preferably has an outer diameter of 14 F to 26 F, andmore preferably between 16 F and 22 F, and most preferably, about 18 F.It can be appreciated that the valve described herein could also bescaled upward in size for other uses in addition to placement in theurethra. The configuration of valve 10 allowing for the production ofrelatively high flow rate valves disposed in housings having smalloutside diameters.

[0020]FIG. 1 shows stopper 30 in a first position A in which proximalportion 31 is in engagement with valve seat 20. FIG. 2 is a view ofvalve 10 of FIG. 1 in which stopper 30 is shown in a second position B.In position B, the pressure at the proximal end of valve 10 hasincreased enough to move stopper 30 away from valve seat 20. Stopper 30is still, however, disposed within first lumen portion 22. The distaldiameter portion 34 of stopper 30 engages the luminal wall of portion22. Thus, there is still no flow through lumen 14, as is the case whenstopper 30 is in engagement with seat 20.

[0021]FIG. 3 is a view of valve 10 of FIGS. 1 and 2. In FIG. 3, stopper30 is disposed in yet another second position C. In position C, portion34 of stopper 30 is disposed within second lumen portion 24. Diameter D₄of lumen portion 24 is sufficiently large to allow flow around plungerportion 34 of stopper 30, as shown by the arrows in lumen 14. Inposition C, the flow between slope 28 of lumen portion 24 and slopingportion 35 of stopper 30 can create a negative pressure in accordancewith Bernoulli Principle. The negative pressure tends to draw stopper 30in a distal direction. Once the flow subsides, however, the forcegenerated in accordance with the Bernoulli Principle will cease andstopper 30 will move proximally toward valve seat 20. If the pressure inthe proximal portion of lumen 14 is sufficiently low, stopper 30 willreturn to position A.

[0022] As can be seen in FIGS. 1, 2 and 3 as stopper 30 moves fromposition A to B and then to C, helical spring portion 38 elongates in adistal direction. Thus, rather than compressing portion 38, springportion 38 is elongated under tension loading.

[0023] Numerous characteristics and advantages of the invention coveredby this document have been set forth in the foregoing description. Itwill be understood, however, that this disclosure is, in many respects,only illustrative. Changes may be made in details, particularly inmatters of shape, size and ordering of steps without exceeding the scopeof the invention. The invention's scope is, of course, defined in thelanguage in which the appended claims are expressed.

What is claimed is:
 1. A valve for a bladder control device, comprising: an elongate housing having a proximal end and a distal end, and a lumen extending therethrough; a valve seat disposed within the housing; a stopper disposed within the housing and moveable between a first position engaging the valve seat and a second position disposed distally of the valve seat; and a tension spring connected to the stopper disposed to biases the stopper toward the valve seat, the spring being under greater tension loading when the stopper is in the second position than when the stopper is in the first position.
 2. The valve in accordance with claim 1 , wherein the spring includes a helical portion.
 3. The valve in accordance with claim 1 , wherein the spring is disposed distally of the stopper.
 4. The valve in accordance with claim 3 , wherein the spring includes an elongate shaft portion, having a proximal end and a distal end, the proximal end of the shaft portion being connected to the stopper, and the distal end of the shaft portion being connected to a helical portion.
 5. The valve in accordance with claim 1 , wherein the stopper includes a proximal portion having a first diameter.
 6. The valve in accordance with claim 5 , wherein the stopper includes a distal portion having a second diameter greater than the first diameter.
 7. The valve in accordance with claim 6 , wherein a first portion of the lumen disposed distally of the valve seat has a diameter approximately equal to the second diameter of the stopper and the stopper is slidably disposed therein for movement between the first and second positions.
 8. The valve in accordance with claim 7 , wherein a second portion of the lumen disposed distally of the first portion of the lumen has a diameter greater than the diameter of the first portion of the lumen.
 9. The device in accordance with claim 8 , wherein a third portion of the lumen disposed distally of the second portion of the lumen has a diameter less than the diameter of the second portion of the lumen.
 10. The valve in accordance with claim 1 , wherein the housing has an outer diameter of between 16 F to 22 F.
 11. The valve in accordance with claim 10 , wherein the outside diameter of the housing is approximately 18 F.
 12. A valve for a bladder control device, comprising: an elongate housing having a proximal end, a distal end, and a lumen extending therethrough; a valve seat disposed within the housing; a stopper disposed within the housing and moveable between a first position engaging the valve seat and a second position disposed distally of the valve seat, the stopper includes a proximal portion having a first diameter and a distal portion having a second diameter greater than the first diameter; a spring connected to the stopper to bias the stopper toward the valve seat; and wherein a first portion of the lumen is disposed distally of the valve seat and has a diameter approximately equal to the second diameter of the stopper, and the stopper is slidably disposed in the first portion of the lumen for movement between the first and second positions, and a second portion of the lumen, having a diameter greater than the diameter of the first portion of the lumen, is disposed distally of the first portion of the lumen.
 13. The valve in accordance with claim 12 , wherein the spring comprises a tension spring being under greater tension loading when the stopper is in the second position than when the stopper is in the first position.
 14. The valve in accordance with claim 12 , wherein the spring includes a helical portion.
 15. The valve in accordance with claim 12 , wherein the spring is disposed distally of the stopper.
 16. The valve in accordance with claim 15 , wherein the spring includes an elongate shaft portion including a proximal end and a distal end, the proximal end of the shaft portion is connected to the stopper and the distal end of the shaft portion is connected to the helical portion.
 17. The valve in accordance with claim 12 , wherein a third portion of the lumen, disposed distally of the second portion of the lumen, has a diameter greater than the diameter of the second portion of the lumen.
 18. The valve in accordance with claim 12 , wherein the housing has an outer diameter between about 16 F to 22 F.
 19. The valve in accordance with claim 18 , wherein the outside diameter of the housing is approximately 18 F. 